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Trial Title:
A Study of Tumor Imaging With Multispectral Optoacoustic Tomography
NCT ID:
NCT05488483
Condition:
Breast Cancer
Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
Multispectral Optoacoustic Tomography Imaging
MSOT
Memorial Sloan Kettering Cancer Center
21-374
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Multispectral Optoacoustic Tomography Imaging
Description:
Each participants will undergo MSOT imaging of the suspicious breast tumor detected with
ultrasound imaging and any additional lesion present in either breast before undergoing
ultrasound-guided breast biopsy as the standard of care. Melanoma participants with
pathologically confirmed ITM will undergo MSOT imaging following physical exam and
biopsy. Melanoma patients receiving immunotherapy will undergo MSOT imaging prior to and
following immunotherapy.
Arm group label:
Breast and Melanoma Cohort
Other name:
MSOT
Summary:
Participants in this study will have Multispectral Optoacoustic Tomography/MSOT imaging
of both breasts immediately before their ultrasound-guided breast biopsy procedure
begins. After the MSO imaging is completed, participation in the study will end.
Criteria for eligibility:
Study pop:
Participants with a suspicious breast imaging finding detected on either mammography,
ultrasound or MRI that is visible on ultrasound and therefore recommended for
ultrasound-guided breast biopsy (BI-RADS 4 suspicious abnormality; BI-RADS 5, highly
suggestive for malignancy) who are scheduled for ultrasound-guided breast biopsy by the
Memorial Sloan Kettering Department of Radiology Breast Imaging Service will be included.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Participant is a female or male who is 18 years of age or older.
- Participant must meet one of the following:
- Suspicious breast imaging finding detected on either mammography, ultrasound,
or MRI that is visible on ultrasound and therefore recommended for
ultrasound-guided breast biopsy (BI-RADS 4 suspicious abnormality; BI-RADS 5,
highly suggestive for malignancy)
- No previous treatment for breast cancer
- Diagnosis of melanoma
Exclusion Criteria:
- Life expectancy < 3 months
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Memorial Sloan Kettering Bergen (Consent only )
Address:
City:
Montvale
Zip:
07645
Country:
United States
Facility:
Name:
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Consent only)
Address:
City:
Commack
Zip:
11725
Country:
United States
Facility:
Name:
Memorial Sloan - Kettering Cancer Center
Address:
City:
New York
Zip:
10021
Country:
United States
Facility:
Name:
Helmholtz Institute (Data Analysis Only)
Address:
City:
Munich
Country:
Germany
Start date:
July 27, 2022
Completion date:
July 27, 2025
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05488483
http://www.mskcc.org